Study On The Preparatiao Process And Quality Control Of Anti-Gout Granuie

Objective: Based on TCM pharmaceutical theories,this study will apply modern pharmaceutical technologies,analysis and extractive methods to refine traditional decoctions into modern Anti-gout Granule,and then identify its main ingredients Clerodranthus picatus,Golden cypress,Ash Bark,Chinese Starjasmine Stem,Folium cortex eucommiae and Astragalus membranaceus.Methods: Under the govern of TCM pharmaceutical theories,screen the extraction,alcohol precipitation and forming process during granule preparation though the orthogonal and single factor experiment.During the study,the orthogonal experiment and composite score method will be combined to optimize the best water-extract process with the investigation targets of general flavone and rosmarinic acid.Secondly,optimize the best water-extract process with the investigation targets of the berberine hydrochloride and chlorogenic acid contents and the extract-acquiring rate.Thirdly,compare different alcohol precipitation with the investigation targets of effective composes to optimize the best water-extract process.Lastly,investigate the concentration,pelletization and granula desiccation to optimize best preparation process.Identify the Clerodranthus picatus,Astragalus membranaceus and Ash Bark of the compound though TLC.Detect the contents of rosmarinic acid,berberine hydrochloride and chlorogenic acid.And then,check the Anti-gout Granule according to Chinese pharmacopoeia(2015),so that to build a reasonable and scientific quality control system for Anti-gout Granule.Results:The best extraction process of compound is: perform reflux extraction 1h/3times to Clerodranthus picatus,Chinese Starjasmine Stem which is added 8 times 60% ethyl alcohol,filtrate the extraction and recollect the ethyl alcohol.Combine the dregs with other 4 drugs and add 14 times water to immerse,25 minutes later,cook it for 3 times with 1hour poor minute,combine the solution and filtrate,concentrate the solution to1.1(measure at 55~60℃).When the solution become cold add in ethyl alcohol to 50%,and then,continue to reduce the pressure to get thick paste with a concentration of 1.30~1.35(measure at 55~60℃).Mix in sugar by rate of 1/3and granulate,subpackage it when it is dried.TCL: Build up the thin-layer chromatography identification method of thin-layer chromatography,the result shows that same color spot appears in certain position.HPLC: Test the contents of rosmarinic acid,berberine hydrochloride and chlorogenic acid though HPLC,the regression equation of rosmarinic acid is Y=44744X-64.04(r=0.9999),the linearity range is 0.00952~0.04760mg/ml.The regression equation of berberine hydrochloride is Y=19284X-4.6267(r=0.9999,the linearity range is 0.00614 ~ 0.03684mg/ml.The regression equation chlorogenic acid is Y = 1826.8X+21.107(r=0.9994),the linearity range is0.182 ~ 1.092μg.The quantitative method is simple and repeatable which satisfy the quality control target.The result conform to requirement of Chinese pharmacopoeia(2015).conclusion: Initially confirmed the best preparation process and quality control of the Anti-gout Granule,the method is available which can control the quality of the preparation effectively,this result provide a theoretical foundation for the further exploration of Clerodranthus picatus resources.